Under
federal regulation, sponsors are responsible for ensuring the integrity of
safety and efficacy data submitted to the FDA to support their application;
they are also responsible for ensuring clinical studies are conducted in
accordance with the approved protocol. Audits are an opportunity to assess
compliance and not just the quality of data, but the systems that generate that
data. This web seminar will highlight the collaborative requirements for
facilitating remote auditing and identify key considerations for future
studies.
- Review the purpose and process of audits
- Examine critical Clinical
Investigator quality systems, subsystems, and processes
- Explore study risk assessments to
inform the remote auditing plan
- Discuss the use of technology to
verify objective evidence
- Address challenges and potential
solutions of virtual audits
- Incorporate new FDA guidance and ISO
standards to develop a remote audit process
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance
Professionals
- Clinical Research Associates
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators
- Clinical Principal Investigators
- IRB Administrators and Members
Elizabeth
Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
$1,195
Includes up to 20 participants at one site. All participants
(up to 20) are eligible for “Certificates of Attendance,” and accreditation,
provided that accreditation requirements are met. For groups larger than 20 or
for additional sites, please call +1 781.972.5400 or toll-free in the U.S.
800.856.2556 for pricing.
Barnett International is accredited by the Accreditation
Council for Pharmacy Education as a provider of continuing pharmacy
education. Participants will receive 6 hours (0.6 CEUs) of continuing
education credit for full participation, including the completion of a
pre-test, post-test, and program evaluation. Barnett International
will issue a receipt of completion for earned CEUs within three weeks of
program completion. ACPE#: 0778-0000-20-091-L04-P. Released: 4/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.